Meta AnalysisID 3172

叶黄素和玉米黄质降低早产儿发病率和死亡率的系统评价 [Cochrane方案]

CRD42016045942

To assess the effectiveness of lutein and zeaxanthin supplementation used for reducing morbidity and mortality in preterm infants. To assess any adverse effects of lutein and zeaxanthin for this purpose. To consider the

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Record Fields

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Meta Analysis Id
3172
Evidence Id
11730
Core Evidence Id
11730
Source Meta Analysis Id
3121
Herb2 Meta Analysis Id
HBMA003121
Crd Id
CRD42016045942
Title
Lutein and zeaxanthin for reducing morbidity and mortality in preterm infants [Cochrane Protocol]
Review Question
To assess the effectiveness of lutein and zeaxanthin supplementation used for reducing morbidity and mortality in preterm infants. To assess any adverse effects of lutein and zeaxanthin for this purpose. To consider the effect of the supplementation in terms of route, dose and timing.
Study Type Included
We will include randomised controlled trials (RCTs) and quasi-RCTs. We will include cluster-RCTs and analyse the unit of analysis issues accordingly.
Condition Being Studied
The Cochrane Neonatal Group
Participant
We will include studies that include preterm infants (equal or less than 37 completed weeks postmenstrual age (PMA)).
Animal
Human Disease Modelled
Intervention
We will include studies in which lutein and zeaxanthin supplementation, either alone or in combination, are administered in any form and by any route and the effects compared to placebo or no supplementation. We anticipate three primary comparison groups; lutein vs control, zeaxanthin vs control, and a combination of lutein and zeaxanthin vs control. We will also include studies in which lutein and zeaxanthin supplementation, either alone or in combination, are co-administered with co-interventions, such as prebiotics or probiotics, for the prevention of retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD) or necrotizing enterocolitis (NEC) or any pharmacological interventions that target specific conditions, such as BPD and patent ductus arteriosus (PDA), provided both groups received them in similar forms. We will set a minimum duration of supplementation for one week for the studies to be eligible for inclusion. Due to the current lack of knowledge on the period during which lutein and zeaxanthin are effective, we do not plan to limit the age when the intervention must be started, and we will accept the period of commencement of the intervention as specified by the authors of the individual studies.
Comparator Control
We will include studies in which lutein and zeaxanthin supplementation, either alone or in combination, are administered in any form and by any route and the effects compared to placebo or no supplementation. We anticipate three primary comparison groups; lutein vs control, zeaxanthin vs control, and a combination of lutein and zeaxanthin vs control.
Main Outcome
<ol> Incidence of any stage of ROP (ICROP 2005). Incidence of ROP stage 3 and above (ICROP 2005). Incidence of visual impairment (clinically assessed with any objective tool such as a visual acuity chart). Vision is tested at nine months using grating acuity cards or its equivalent (Dobson 1990; Hardy 2004; Teller 1986). Final visual acuity is tested at six years of age (Good 2010), using Early Treatment Diabetic Retinopathy Study (ETDRS) letter acuity chart or its equivalent (Ferris 1982). Mortality at 28 days and at discharge. </ol>
Outcome Measure
Additional Outcome
<ol> Incidence of intraventricular haemorrhage (IVH) (all grades of IVH and severe IVH grades III and IV) (Papile 1978). Periventricular leukomalacia (PVL). PVL is diagnosed by cranial ultrasonography (cystic PVL) at or after four weeks of age (Townsend 1999), or by magnetic resonance imaging (diffuse PVL) (Counsell 2003) at term corrected age. Incidence of necrotising enterocolitis (NEC): Bell's stage II or greater (Bell 1978). Incidence of BPD at 36 weeks PMA (infants less than 32 weeks PMA) or 56 days of life (infants more than 32 weeks PMA) (Jobe 2001). Patent ductus arteriosus (PDA). PDA is diagnosed clinically by the presence of a PDA murmur, bounding pulses and hyperdynamic precordium with clinical signs of an effect on organ function attributable to the PDA (e.g. respiratory distress, feed intolerance and renal insufficiency); PDA can also be diagnosed echocardiographically by a significant ductus arteriosus effect on blood flow with increased pulmonary blood flow, increased left atrial to aortic root ratio, or absent or reversed flow in the distal aorta or organ arteries (Evans 1993). Healthcare-acquired infections (HAI). HAI is diagnosed by clinical and microbiological methods depending on the possible sources of infection (Polin 2012) or as defined by individual studies. Neurodevelopmental outcome assessed at 18 months to 28 months (Newman 2012). We will accept any of the following outcome alone or in combination: cerebral palsy, mental retardation (Bayley Scales of Infant Development Mental Developmental Index of less than 70), and hearing deficit (aided or less than 60 dB on audiometric testing) or assessment via use of a validated cognitive/language/behavioural/social interaction/adaptive test (Albers 2007). Length of hospital stay (days). Any reported adverse effects. </ol>
Study Method
Intervention, Systematic review
Keyword
Humans; Infant; Infant Health; Infant Mortality; Infant, Newborn; Infant, Premature; Lutein; Morbidity; Treatment Outcome; Xanthophylls; Zeaxanthins
Contact
Yao Mun Choo [email protected]
Organisational Affiliation
The Cochrane Collaboration http://www.cochrane.org/
Funding Source
Taylor''s University, Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Department of Health and Human Services, University of Malaya
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language
English
Country
Australia, Malaysia
Review Stage
Review Ongoing
First Submission Date
Registration Date
2016-08-15
Anticipated Start Date
2016-04-15
Anticipated Completion Date
2016-12-01
Title Cn
叶黄素和玉米黄质降低早产儿发病率和死亡率的系统评价 [Cochrane方案]
Title En
Lutein and zeaxanthin for reducing morbidity and mortality in preterm infants [Cochrane Protocol]
Bilingual Status
complete